By Deidre McPhillips, NCS
(NCS) — The US Food and Drug Administration has reversed course and will review a brand new mRNA flu vaccine from Moderna, the pharmaceutical company stated Wednesday.
About two weeks in the past, the FDA despatched Moderna a letter during which it refused to simply accept the applying to review its first mRNA seasonal flu vaccine — a rare move by the federal company that raised concern about one other setback for the expertise that’s been a goal of some Trump administration well being officers.
The FDA told Moderna that its software didn’t comprise an “adequate and well-controlled” trial as a result of the management arm didn’t mirror the “best-available standard of care in the United States at the time of the study,” in keeping with the letter, that Moderna posted on-line. It didn’t determine any security or efficacy considerations, the company stated.
But Moderna has since met with the FDA and “proposed a revised regulatory approach” with totally different pathways by age, in keeping with a information launch from the company.
Moderna is now “seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults,” the information launch stated.
“Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted,” Andrew Nixon, a spokesperson for the US Department of Health and Human Services, stated in a press release. “FDA will maintain its high standards during review and potential licensure stages as it does with all products.”
If the FDA approves the vaccine, it might be out there for individuals ages 50 and older for the upcoming 2026-2027 flu season.
Last week, Moderna stated that the preliminary refusal from the FDA was inconsistent with earlier suggestions from the company.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel stated in a press release. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
NCS’s Meg Tirrell and Adam Cancryn contributed to this report.
The-NCS-Wire
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